Doxercalciferol in Treating Patients With Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00052832
First received: January 24, 2003
Last updated: August 16, 2013
Last verified: August 2013
  Purpose

RATIONALE: Doxercalciferol may improve low blood cell counts and decrease the need for blood transfusions and may be an effective treatment for myelodysplastic syndrome or chronic myelomonocytic leukemia.

PURPOSE: Phase II trial to study the effectiveness of doxercalciferol in treating patients who have myelodysplastic syndrome or chronic myelomonocytic leukemia.


Condition Intervention Phase
Leukemia
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Diseases
Dietary Supplement: doxercalciferol
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Doxercalciferol for the Treatment of Myelodysplastic Syndromes

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Study Start Date: September 2002
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the response rate of patients with myelodysplastic syndromes or chronic myelomonocytic leukemia treated with doxercalciferol.
  • Determine the toxicity profile of this drug in these patients.
  • Determine the time to progression and overall survival of patients treated with this drug.

OUTLINE: Patients receive oral doxercalciferol daily for 12 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: Approximately 41 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Morphologically and cytogenetically confirmed myelodysplastic syndromes or chronic myelomonocytic leukemia

    • No more than 20% blasts by bone marrow biopsy
  • Must meet at least 1 of the following criteria:

    • Anemia

      • Hemoglobin less than 11 g/dL over a 2-month period
    • Thrombocytopenia
    • Neutropenia

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • See Disease Characteristics

Hepatic

  • ALT and AST less than 1.5 times upper limit of normal
  • Bilirubin less than 3 mg/dL
  • Albumin greater than 3.0 g/dL

Renal

  • Creatinine clearance greater than 50 mL/min
  • No history of hypercalcemia
  • No renal stones within the past 5 years

Cardiovascular

  • No clinically significant heart failure
  • No uncontrolled hypertension

Pulmonary

  • No clinically significant pulmonary failure

Other

  • Not pregnant
  • Fertile patients must use effective contraception during and for 6 months after study

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • At least 4 weeks since prior growth factor or cytokine therapy

Chemotherapy

  • At least 8 weeks since prior cytotoxic chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • Concurrent transfusion support allowed
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00052832

Locations
United States, Wisconsin
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Study Chair: Mark B. Juckett, MD University of Wisconsin, Madison
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00052832     History of Changes
Other Study ID Numbers: CDR0000258754, P30CA014520, WCCC-HO-02403
Study First Received: January 24, 2003
Last Updated: August 16, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Wisconsin, Madison:
chronic myelomonocytic leukemia
previously treated myelodysplastic syndromes
secondary myelodysplastic syndromes
de novo myelodysplastic syndromes
atypical chronic myeloid leukemia
myelodysplastic/myeloproliferative disease, unclassifiable

Additional relevant MeSH terms:
Leukemia
Leukemia, Myelomonocytic, Chronic
Myelodysplastic Syndromes
Preleukemia
Leukemia, Myelomonocytic, Acute
Myeloproliferative Disorders
Myelodysplastic-Myeloproliferative Diseases
Neoplasms by Histologic Type
Neoplasms
Leukemia, Myeloid
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
1 alpha-hydroxyergocalciferol
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on April 23, 2014